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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 3-176
ISO  18193 First edition 2021-08
Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients' blood during cardiopulmonary bypass (CPB) up to 6 h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques. This standard does not apply to:
- introducers (e.g., guidewires) as addressed in ISO 11070,
- isolated organ perfusion cannulae, and
- intravascular catheters as addressed in ISO 10555-3.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.1250 Catheter, Percutaneous Class 2 DQY
§870.1250 Catheter, Angioplasty, Peripheral, Transluminal Class 2 LIT
§870.4100 Dual Lumen Ecmo Cannula Class 2 PZS
§870.4210 Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Class 2 DWF
§880.5200 Catheter, Umbilical Artery Class 2 FOS
§880.5200 Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Class 2 FOZ
§880.5200 Saline, Vascular Access Flush Class 2 NGT
§880.5200 Heparin, Vascular Access Flush Class 2 NZW
§880.5200 Water, Vascular Access Flush Class 2 NZX
§880.5200 Peripheral Catheter Insertion Kit Class 2 OWL
§880.5200 Heparin Flush In 0.45% Sodium Chloride Class 2 PEF
§880.5200 Central Venous Catheter Dressing Change Kit Class 2 PEZ
§880.5970 Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days Class 2 LJS
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, Issued March 1995.
2. Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters - Class II Special Controls Guidance for Industry and FDA, Issued September 2010.
3. Class II Special Controls - Final Order §870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, published February 12, 2016. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=870.4100
4. Intravascular catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations, Guidance for Industry and Food and Drug Administration Staff, Issued October 2019.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Qijin Lu
 Catherine Wentz
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.